End Stage Renal Disease on Dialysis (Diagnosis)NCT03733262
Targeted Deprescribing in Patients on Hemodialysis
An observational study of End Stage Renal Disease on Dialysis (Diagnosis), run by University Health Network, Toronto at 4 sites in Canada.
Trial summary
Hemodialysis (HD) patients take more pills per day on average than any other chronically ill patient population. On average, an HD patient takes 19 medications per day, of which 70% may not be appropriate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis (Diagnosis)
- What is being tested?
- De-prescribing Trial
- How many people
- 480 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Oct 2022to 30 Mar 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There will be approximately 1,200 patients in the outpatient HD units from Toronto (300), Vancouver (200), Winnipeg (400) and Halifax (300). Based on a previous pilot study, it is assumed that 80% of patients have been prescribed at least one of the nine target drugs (i.e., n=960). Of those, it is assumed that 50% will be eligible for the study (i.e., n=480). Of eligible individuals, it is assumed 88% will initiate a De-prescribing Trial (Intervention Group), resulting in an anticipated cohort of n=420.
Who may be able to join
- 18+ years
- Have been receiving outpatient HD treatment at one of the four study sites for at least the past three months
- Able to read and understand English and provide consent
Who cannot join
- Acute starts to HD
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 1 recruiting
- Active, not recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Marisa Batistella, PharmD, 416-340-4800 ext. 3207, marisa.battistella@uhn.ca
Melissa Lefebvre, MBiotech, 4168589786, melissa.lefebvre@uhnresearch.ca
- Active, not recruiting
Providence Health Care
Vancouver, British Colombia, V6Z 1Y6
- Active, not recruiting
Manitoba Renal Program
Winnipeg, Manitoba, R2V 3M3
About this study
Official title: Implementation of Deprescribing and Patient Education Tools in Hemodialysis Units to Decrease Polypharmacy
Hemodialysis (HD) patients take more pills per day on average than any other chronically ill patient population. On average, an HD patient takes 19 medications per day, of which 70% may not be appropriate. The reason the medications may not be appropriate is that HD patients are rarely included in clinical trials for new medications and therefore the efficacy and safety data that exists for the general population may not actually apply to them. Tools to guide the re-assessment and discontinuation (deprescribing) of these specific medications that lack evidence for efficacy and safety in HD patients are needed. These tools will help reduce the amount of medications being taken and the potential negative consequences of taking so many medications (e.g. adverse drug reactions, drug interactions, non-adherence, increased risk of cognitive impairment, impaired balance and falls, and increased risk of morbidity, hospitalization, and mortality).
Nine medications that are often inappropriately prescribed to HD patients have been identified by the investigators. These medications are: Alpha-1 Blockers, Anticonvulsants, Benzodiazepines \& Z-Drugs, Loop Diuretics, Prokinetic Agents, Proton Pump Inhibitors, Quinine, Urate Lowering Agents, and Statins. The investigators developed and validated tools to help medical teams in outpatient HD units with identifying and stopping these medications in their patients. The next step will be to perform a study where test these tools are tested in practice at multiple HD centers across Canada. This initiative should decrease the average number of medications per patient and inappropriate medication use in the HD units where these tools are used. The overall objective of this study is to improve current clinical practice by optimizing medication use and prescribing patterns in the HD units across Canada.
Read the detailed description
Background: Hemodialysis (HD) patients are rarely included in clinical trials, thus medication efficacy and safety data specific to this population is lacking. Toxicity from medications inadequately removed by dialysis is also a risk for them. HD patients take an average of 19 pills daily, with 70% potentially inappropriate.
This polypharmacy increases their risk of adverse events, drug-drug interactions, non-adherence, cognitive impairment, impaired balance and falls, morbidity, hospitalization and mortality. Using provincial databases, the investigators identified 9 medication classes with uncertain indications and/or safety in HD patients: Alpha-1 Blockers, Anticonvulsants, Benzodiazepines \& Z-medications, Loop Diuretics, Prokinetic Agents, Proton Pump Inhibitors, Quinine, Urate Lowering Agents and Statins. The investigators developed and validated tools for deprescribing, safety monitoring and patient education for each of these medications. The next step will be to perform an implementation study evaluating these deprescribing tools at multiple HD units across Canada.
The investigators hypothesize that implementation of these deprescribing tools will decrease polypharmacy and improve safety and patient satisfaction in these HD units. Specific Aims are to determine:
- Effectiveness of the deprescribing algorithms for decreasing polypharmacy (i.e. % of successful deprescribing of at least 1 of the medication classes at 6 month post implementation)
- Safety of the deprescribing algorithms using monitoring tools developed for each medication
- The impact of the deprescribing tools on patient satisfaction
Methods: In this quasi-experimental interventional cohort study, the nephrology healthcare team will assess medications for all patients as per usual practice in their respective HD units, using the deprescribing algorithms to assist in clinical decision making and patient education tools to explain rationale to patients. Participating patients will be followed for 6 months for outcomes.
The primary outcome will be proportion of individuals successfully deprescribed at least one of the 9 target medications.
Additional outcomes include:
- Adverse events associated with deprescribing and medication class specific safety outcomes (e.g. for furosemide, the investigators will be tracking blood pressure, potassium, intradialytic weight gain and heart failure admissions)
- Proportion of identified candidates who began a deprescribing trial
- Proportion of deprescribing trials declined by medical team and patient, respectively
- Patient satisfaction (using a patient survey)
- Average number of medications per patient before/after implementation
- Average medication cost savings per patient
Expected Results/Impact on Health Research: This study will determine the efficacy of the deprescribing algorithms on reducing polypharmacy in HD patients. It will also provide insights on knowledge translation, as investigators aim to educate providers and patients on the harms of polypharmacy and influence prescribing patterns in HD units nationally. This study will encourage other institutions to incorporate similar tools into their practice and encourage comprehensive and team based re-assessment of patient's medications.
- Being tested
- De-prescribing Trial
- Keywords
- deprescribing, hemodialysis, medication optimization, medication prescribing patterns, patient safety, polypharmacy, pill burden, quality improvement activity, chronic kidney disease, end-stage renal disease
- Medical subject headings
- Disease, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-prescribing TrialOther
Validated de-prescribing algorithms will be applied for any patients identified as taking one of the 9 study drugs in order to determine whether or not physician should consider a deprescribing trial. If they are are identified as candidates for deprescribing and consent to participate in the trial, they will enter the Deprescribing Trial group and begin the deprescribing trial.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Patients | There will be approximately 1,200 patients in the outpatient HD units from Toronto (300), Vancouver (200), Winnipeg (400) and Halifax (300). Based on a previous pilot study, it is assumed that 80% of patients have been prescribed at least one of the nine target drugs (i.e., n=960). Of those, it is assumed that 50% will be eligible for the study (i.e., n=480). Of eligible individuals, it is assumed 88% will initiate a De-prescribing Trial (Intervention Group), resulting in an anticipated cohort of n=420. Receives: Other: De-prescribing Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who began any of the 9 deprescribing trials who have successfully stayed off that medications by the end of the study
Numbers will be given for each of the 9 drug classes and overall
Measured: 1 year
Secondary outcomes (6)
Number of patients who were identified as candidates for a deprescribing trial, after an assessment using one of the nine deprescribing algorithms
Numbers will be given for each of the 9 drug classes and overall
Measured: 1 year
Number of patients who were identified as candidates for a deprescribing trial (after an assessment using one of the nine deprescribing algorithms) but who did not begin a deprescribing trial due to refusal by the medical team
Numbers will be given for each of the 9 drug classes and overall
Measured: 1 year
Number of patients who were identified as candidates for a deprescribing trial (after an assessment using one of the nine deprescribing algorithms) but who did not begin a deprescribing trial due to refusal by the patient
Numbers will be given for each of the 9 drug classes and overall
Measured: 1 year
Average number of medications (including target medications and any other medications) per patient before and after this deprescribing implementation study
Average number of medications (including target medications and any other medications) per patient before and after this deprescribing implementation study
Measured: 1 year
Change in patient satisfaction scores pre-intervention vs. post-intervention, as assessed by patient satisfaction surveys (developed for this study) administered before the study and 6 months after the study start date
The patient satisfaction survey is based on the Consumer Assessment of Healthcare Providers \& Systems (CAHPS®) In-Center HD Survey, which rates the medication and dialysis services. Most questions are on a Likert scale ranging from Never (1) to Always (4) or from Strongly Disagree (1) to Strong Agree (5). There are also two No (1) / Yes (2) questions and one 0 (Worst possible) to 10 (Best possible) question. The survey is divided into 3 sections: Dialysis Center Staff, Your Medications, and Deprescribing.
The average total score overall for patients before vs. after the study will be compared (higher scores indicate higher satisfaction). The average total score per section for patients before vs. after the study will also be compared.
Measured: 1 year
Number of participants with treatment-related adverse events, as assessed by patient monitoring app (developed for this study)
The study app will track at adverse events associated with deprescribing each of the specific medication classes. For example: for loopdiuretics, blood pressure, potassium, intradialytic weight gain and heart failure admissions will be tracked; for proton pump inhibitors, gastroesophageal reflux disease (GERD) symptom severity and frequency of antacid use will be tracked
By comparing baseline symptoms to symptoms during and at the completion of deprescribing, safety concerns will be identified.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Oct 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on Dialysis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marisa Battistella, University Health Network, Toronto
- Investigators
- Marisa Battistella, PharmD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733262
- Sponsor's protocol ID
- 17-5313
- Status last verified
- May 2024
- First submitted
- 2 Nov 2018
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zlotnik N, Abbaticchio A, Theodorlis M, Cross MS, Kitchlu A, Wilson JA, Gagliardi AR, Battistella M. Medication Mindfulness: Implementation and Evaluation of a Single-Site, 6-Month Deprescribing Intervention for Patients on Hemodialysis. Kidney360. 2025 Dec 1;6(12):2196-2207. doi: 10.34067/KID.0000000884. Epub 2025 Jun 26.
PubMed 40569679
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Deprescribing and Patient Education Tools in Hemodialysis Units to Decrease Polypharmacy
- ClinicalTrials.gov ID
- NCT03733262
- Acronym / sponsor ID
- 17-5313
- Keywords
- deprescribing, hemodialysis, medication optimization, medication prescribing patterns, patient safety, polypharmacy, pill burden, quality improvement activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemodialysis (HD) patients take more pills per day on average than any other chronically ill patient population. On average, an HD patient takes 19 medications per day, of which 70% may not be appropriate. The reason the medications may not be appropriate is that HD patients are rarely included in clinical trials for new medications and therefore the efficacy and safety data that exists for the general population may not actually apply to them. Tools to guide the re-assessment and discontinuation (deprescribing) of these specific medications that lack evidence for efficacy and safety in HD patients are needed. These tools will help reduce the amount of medications being taken and the potential negative consequences of taking so many medications (e.g. adverse drug reactions, drug interactions, non-adherence, increased risk of cognitive impairment, impaired balance and falls, and increased risk of morbidity, hospitalization, and mortality).
Nine medications that are often inappropriately prescribed to HD patients have been identified by the investigators. These medications are: Alpha-1 Blockers, Anticonvulsants, Benzodiazepines \& Z-Drugs, Loop Diuretics, Prokinetic Agents, Proton Pump Inhibitors, Quinine, Urate Lowering Agents, and Statins. The investigators developed and validated tools to help medical teams in outpatient HD units with identifying and stopping these medications in their patients. The next step will be to perform a study where test these tools are tested in practice at multiple HD centers across Canada. This initiative should decrease the average number of medications per patient and inappropriate medication use in the HD units where these tools are used. The overall objective of this study is to improve current clinical practice by optimizing medication use and prescribing patterns in the HD units across Canada.
Detailed description
Background: Hemodialysis (HD) patients are rarely included in clinical trials, thus medication efficacy and safety data specific to this population is lacking. Toxicity from medications inadequately removed by dialysis is also a risk for them. HD patients take an average of 19 pills daily, with 70% potentially inappropriate.
This polypharmacy increases their risk of adverse events, drug-drug interactions, non-adherence, cognitive impairment, impaired balance and falls, morbidity, hospitalization and mortality. Using provincial databases, the investigators identified 9 medication classes with uncertain indications and/or safety in HD patients: Alpha-1 Blockers, Anticonvulsants, Benzodiazepines \& Z-medications, Loop Diuretics, Prokinetic Agents, Proton Pump Inhibitors, Quinine, Urate Lowering Agents and Statins. The investigators developed and validated tools for deprescribing, safety monitoring and patient education for each of these medications. The next step will be to perform an implementation study evaluating these deprescribing tools at multiple HD units across Canada.
The investigators hypothesize that implementation of these deprescribing tools will decrease polypharmacy and improve safety and patient satisfaction in these HD units. Specific Aims are to determine:
- Effectiveness of the deprescribing algorithms for decreasing polypharmacy (i.e. % of successful deprescribing of at least 1 of the medication classes at 6 month post implementation)
- Safety of the deprescribing algorithms using monitoring tools developed for each medication
- The impact of the deprescribing tools on patient satisfaction
Methods: In this quasi-experimental interventional cohort study, the nephrology healthcare team will assess medications for all patients as per usual practice in their respective HD units, using the deprescribing algorithms to assist in clinical decision making and patient education tools to explain rationale to patients. Participating patients will be followed for 6 months for outcomes.
The primary outcome will be proportion of individuals successfully deprescribed at least one of the 9 target medications.
Additional outcomes include:
- Adverse events associated with deprescribing and medication class specific safety outcomes (e.g. for furosemide, the investigators will be tracking blood pressure, potassium, intradialytic weight gain and heart failure admissions)
- Proportion of identified candidates who began a deprescribing trial
- Proportion of deprescribing trials declined by medical team and patient, respectively
- Patient satisfaction (using a patient survey)
- Average number of medications per patient before/after implementation
- Average medication cost savings per patient
Expected Results/Impact on Health Research: This study will determine the efficacy of the deprescribing algorithms on reducing polypharmacy in HD patients. It will also provide insights on knowledge translation, as investigators aim to educate providers and patients on the harms of polypharmacy and influence prescribing patterns in HD units nationally. This study will encourage other institutions to incorporate similar tools into their practice and encourage comprehensive and team based re-assessment of patient's medications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Patients | – | Other: De-prescribing TrialThere will be approximately 1,200 patients in the outpatient HD units from Toronto (300), Vancouver (200), Winnipeg (400) and Halifax (300). Based on a previous pilot study, it is assumed that 80% of patients have been prescribed at least one of the nine target drugs (i.e., n=960). Of those, it is assumed that 50% will be eligible for the study (i.e., n=480). Of eligible individuals, it is assumed 88% will initiate a De-prescribing Trial (Intervention Group), resulting in an anticipated cohort of n=420. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There will be approximately 1,200 patients in the outpatient HD units from Toronto (300), Vancouver (200), Winnipeg (400) and Halifax (300). Based on a previous pilot study, it is assumed that 80% of patients have been prescribed at least one of the nine target drugs (i.e., n=960). Of those, it is assumed that 50% will be eligible for the study (i.e., n=480). Of eligible individuals, it is assumed 88% will initiate a De-prescribing Trial (Intervention Group), resulting in an anticipated cohort of n=420.
Key inclusion criteria (3 listed)
- 18+ years
- Have been receiving outpatient HD treatment at one of the four study sites for at least the past three months
- Able to read and understand English and provide consent
Key exclusion criteria (1 listed)
- Acute starts to HD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| De-prescribing TrialValidated de-prescribing algorithms will be applied for any patients identified as taking one of the 9 study drugs in order to determine whether or not physician should consider a deprescribing trial. If they are are identified as candidates for deprescribing and consent to participate in the trial, they will enter the Deprescribing Trial group and begin the deprescribing trial. | Other | Hemodialysis Patients |
Primary outcome
Number of patients who began any of the 9 deprescribing trials who have successfully stayed off that medications by the end of the study
Time frame: 1 year
Numbers will be given for each of the 9 drug classes and overall
6 secondary outcomes
Number of patients who were identified as candidates for a deprescribing trial, after an assessment using one of the nine deprescribing algorithms
Time frame: 1 year
Number of patients who were identified as candidates for a deprescribing trial (after an assessment using one of the nine deprescribing algorithms) but who did not begin a deprescribing trial due to refusal by the medical team
Time frame: 1 year
Number of patients who were identified as candidates for a deprescribing trial (after an assessment using one of the nine deprescribing algorithms) but who did not begin a deprescribing trial due to refusal by the patient
Time frame: 1 year
Average number of medications (including target medications and any other medications) per patient before and after this deprescribing implementation study
Time frame: 1 year
Change in patient satisfaction scores pre-intervention vs. post-intervention, as assessed by patient satisfaction surveys (developed for this study) administered before the study and 6 months after the study start date
Time frame: 1 year
Number of participants with treatment-related adverse events, as assessed by patient monitoring app (developed for this study)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 40569679Zlotnik N, Abbaticchio A, Theodorlis M, Cross MS, Kitchlu A, Wilson JA, Gagliardi AR, Battistella M. Medication Mindfulness: Implementation and Evaluation of a Single-Site, 6-Month Deprescribing Intervention for Patients on Hemodialysis. Kidney360. 2025 Dec 1;6(12):2196-2207. doi: 10.34067/KID.0000000884. Epub 2025 Jun 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisa Battistella, PharmD principal investigator
University Health Network, Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease on Dialysis (Diagnosis), run by University Health Network, Toronto at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marisa Battistella, PharmD (416-340-4800 ext. 3207, marisa.battistella@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who began any of the 9 deprescribing trials who have successfully stayed off that medications by the end of the study (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.